Anthony Clayton
Themes it raises
1 of the 21 themes in the docket, each with the passage we counted, verbatim.
How this fits rules that already existFDA Q8, Q9, Q16, Q25
“We need some leadership at the Federal level to set standards and get State level organizations to agree to common standards in healthcare.”
Machine-assisted draft, pending human review. The source text and highlighted passages appear below. Read the filing on regulations.gov ↗
The comment as filed
Comment submitted on regulations.gov. Passages we counted are highlighted.
IMHO, as with most, we are hoping for some leadership and co-ordination for establishing US standards, universal datasets and legal certainty. Example, sad/hilarious that a state can refuse to accept results of clinical studies performed outside that state because the study was not performed on citizens of that particular state (looking at you CA). We need some leadership at the Federal level to set standards and get State level organizations to agree to common standards in healthcare. The technology capability is here, its leadership that is lacking. Just my 2c from 30yrs of obseving healthtech adoption in the US.